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NCT03092882 Clinical Trial

Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Digital Self-Management Program for Medicare Advantage Members With Type 2 Diabetes- Impact on A1c

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03092882
Other study ID # EH-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2017
Est. completion date February 7, 2018

Study information
Verified date June 2019
Source Evidation Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Digital Self-Management Program for Medicare Advantage Members with Type 2 Diabetes - Impact on A1c trial is a 26-week long, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Digital Self-Management Program on A1c levels for individuals with uncontrolled Type 2 diabetes.

Recruitment information / eligibility
Status Completed
Enrollment 607
Est. completion date February 7, 2018
Est. primary completion date February 7, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Humana Medicare Advantage member

- Type 2 diabetes diagnosis

- HbA1c levels = 8.0% verified by lab test

Exclusion Criteria:

- Has any of the following conditions: cancer, chronic heart failure, chronic obstructive pulmonary disease, respiratory failure, chronic kidney disease, end stage renal disease, peripheral vascular disease

- Not fluent in English

- Humana membership is part of a Full or Global risk arrangement

- Enrolled in Humana at Home Care Management

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Diabetes Self-Management Program
The Diabetes Self-Management Program is a platform that includes a smart meter, access to coaching 24/7, and a mobile app and website that help members manage their diabetes. The program offers diabetes education and coaching delivered entirely through the smart meter and mobile app or website.

Locations
Country Name City State
United States Evidation Health San Mateo California

Sponsors (2)
Lead Sponsor Collaborator
Evidation Health Humana Co.Ltd.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline in A1c at 6 months Change in A1c from study baseline to study end Baseline and 6 months
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